CEOCFO: Dr. Gupta, what was the vision
when Asana BioSciences was founded in 2014? What is the focus today?

Dr. Gupta, PhD:When we founded
the company in 2014, our vision was to be a company that provides novel
drugs, both small molecule and biologics, which address’s unmet needs of
patients and provide treatment options to physicians and payers alike. We
are still involved in that endeavor. We have multiple programs in Phase II
clinical development and a number of programs in Phase I clinical
development. Our focus, as we started back in 2014, remains in the areas of
inflammation/immunology and oncology. We are a drug discovery and
development company and we have made significant progress towards our
mission of delivering novel and differentiated treatments options to
patients and physicians and addressing unmet clinical needs.

CEOCFO: What are you working on
specifically? What are you trying to accomplish and what have you developed
so far?

Dr. Gupta, PhD:We started as a
drug discovery and preclinical development company back in 2014. As I
indicated, we have progressed to become a clinical stage company. We
recently demonstrated clinical proof of concept in moderate-to-severe atopic
dermatitis patients (also known as chronic eczema) where we have shown that
our drug ASN002, a novel inhibitor of JAK and SYK kinase pathways, provides
very fast relief from chronic itch associated with eczema, as well as
modifying the disease by reducing the inflammation towards normal, non-itchy
skin; i.e. lesional skin to non-lesional skin. In addition, we have
significant drug development efforts in the area of cancer, two of our
molecules are currently in late Phase 1 clinical development using precision
medicine approach.

CEOCFO: What is happening in the
body? What is it in your drug that is acting with the problem that makes a
difference that has not been done before?

Dr. Gupta, PhD:
As I said before, we are developing our lead drug ASN002, an oral drug, for
moderate-to-severe atopic dermatitis. Atopic dermatitis is driven by
inflammation, when the body’s immune system produces a number of immunogenic
molecules, which are known as cytokines, and some other factors. When
inflammation is manifested in the skin, it can lead to eczema or atopic
dermatitis. There are other drugs which are in development or on the market,
such as steroids and some antibodies, which do provide relief against itch
and skin inflammation in atopic dermatitis. Our clinical proof of concept
study showed that ASN002 provides very fast symptom relief, and also
converts the diseased skin back to normal skin. It does so by targeting
multiple cytokine pathways in the blood as well as directly in the skin,
which has not been reported for other oral drugs. Therefore, we anticipate
that in the current clinical trials, in which patients are treated for
longer duration than in our proof of concept study, we will demonstrate a
more durable response, resulting in longer term patient benefit and the
opportunity to reverse the disease completely. In summary, our drug could
potentially provide a disease modifying treatment that will make the skin of
an atopic dermatitis patient return to normal, healthy skin.

CEOCFO: What else is in the group that you
are working on?

Dr. Gupta, PhD:Another drug that
we are working on in this arena of inflammation and immunology is a topical
product. It is not a tablet or injectable, it is a gel that you apply to
skin. We have shown that this drug, when applied on an animal that is
scratching vigorously because of an itch, can provide fifteen plus hours of
relief with a single application. This is unique because there are no other
treatments that can provide such long-lasting relief with such a fast onset
of action. We have compared the effects of our drug with other topical
agents that only provide relief for an hour or two, so we are very excited
about this differential characteristic and potential benefit to patients.
This molecule, ASN008, will enter clinical trials in patients soon. We have
finished all the safety studies and other activities needed for an FDA
application to start the investigation of this new drug. Another major focus
of the company’s discovery and development efforts, outside of immunology
and inflammation, is oncology. We are working on novel treatments for a
number of cancers. Our approach in the cancer area is precision medicine. We
are looking to develop drugs that target specific genetic mutations. In the
body, when the cancer takes over, sometimes there are genes that get altered
very specifically. A particular mutated gene can cause cancer cells to grow
uncontrollably, at a much faster rate than normal healthy cells. What we are
working on is to selectively target the products of these specific mutant
genes to stop the tumor growth. We have two drugs in our clinical
development pipeline right now that are being evaluated in humans in Phase I
trials, and we are trying to move these programs into more advanced studies
by early next year. Right now, we are looking at the dosing, safety and
early clinical responses to understand how well the drug is working, and
then we will study these drugs in patient populations with specific types of
melanoma, non-small cell lung cancer, colorectal cancer and pancreatic
cancer, etc. There is still a high unmet medical need for patients with
these cancers as there are not many active and well tolerated treatment
options available. We believe our drugs will provide new treatment options
to these patients.

CEOCFO: What have you learned as you have
been working on these various drugs? What surprised you so far, if anything?

Dr. Gupta, PhD:We have always
known that drug development is not easy, there are many unknowns. The
question is, when you are presented with certain bits and pieces of data,
what do you do with it. One needs to make a decision whether to continue on
the same path or if one should change course. What we have learned as a
team, as a company, is to evaluate the data early and very critically as it
is emerging from animal or patient trials, and then do course corrections as
needed. Look at what would be the best path forward based on the data, come
to a conclusion, and then move the program forward expeditiously.

CEOCFO: Is there a place for gut feeling,
given your experience that comes into play or is it strictly what you see in
front of your eyes?

Dr. Gupta, PhD:What is in front
of your eyes is the data. Sometimes the direction you choose is not only
driven by data alone, your past experiences also shape the future path. At
Asana, ultimate drug development decisions are never based on gut feeling
alone. There is a little bit of gut feeling involved for certain aspects,
for example with how much risk you want to take in certain areas. It does
come into the picture from time to time, but once again, we are a science
and data driven company, so we don’t rely much on gut feeling;we rely primarily on scientific and clinical data. When new data
emerges, we critically review it and assess the options it provides us. As I
said before, gut feeling is based on experience and is only used to choose
between the viable options based on the data, rather than overruling data.

CEOCFO: What has been the reaction from
the medical and scientific community that is aware of what you are doing at
Asana?

Dr. Gupta, PhD:Clearly, there is
a lot of excitement over what we are doing. It is important to understand
that Asana BioSciences is a very small and young company, but we have been
successful in parallel development of multiple drugs. The medical community
and the opinion leaders look at our efforts in this area and they are quite
pleasantly surprised with what we have achieved with a small, but
experienced team and focused resources. We have been able to make decisions
and move programs forward quickly from preclinical into clinical
development. What they are also excited about is, again, our ability to look
at the data and change course if needed. For example, we were initially
developing our atopic dermatitis drug ASN002, a dual JAK and SYK inhibitor,
for cancer. However, in the cancer trial we had also incorporated some
measurements to keep an eye on what happens to the inflammatory process in
general. When that data started to emerge and after evaluating those data,
we had a choice to make. We had three options in front of us; whether to
ignore inflammation biomarker data and continue our efforts in oncology
where we were developing the drug in Non-Hodgkin’s Lymphoma and certain
other indications, and where we had seen good clinical activity; or start
the development in immunological and inflammatory diseases in parallel. The
third option was to stop oncology development and focus on immunologic
disease such as atopic dermatitis and other immunologic diseases. The
initial data was very, very interesting and intriguing, so what we ended up
doing was creating a parallel effort first. Then we said, “Okay, we
understand what happens in cancer patients, let us see what happens in
atopic dermatitis patients.” Therefore, we ran a quick, placebo-controlled
study with high scientific rigor and tested the hypothesis. In a few months,
we received the data from atopic dermatitis patients and then evaluated our
options. Now once again, we had three options. The drug was performing well
in cancer. We were seeing certain responses; those data were quite
interesting from the cancer’s and from our patient’s perspective. However,
when we looked at the atopic dermatitis data, it was much more robust. At a
small company, with the resources we had, now we had to decide whether to
continue clinical development in two different therapeutic areas, or focus.
We considered all available data, our understanding of the competitive
landscapes in these areas, the potential for differentiation, and different
paths to success. After evaluating all aspects, we decided to prioritize the
development of the drug in atopic dermatitis and other immunologic diseases,
with focus and full force.

CEOCFO: Are you seeking funding,
investments and partnerships as you move forward?

Dr. Gupta, PhD:Yes, of course.
As a young company, it is very important to continue moving on our path,
generate the right data for our development products and take our programs
to the decision points. But as you know, pharma/biotech is a large capital
investment arena. Therefore, we always continue to evaluate interest in
terms of partnering, strategic partners as well as investors. The question
is - when do we think is the right time for us to tap external investors or
strategic partners. Currently, Asana is a well-funded private company. Our
investors are experienced, savvy and highly successful. They have pharma
experience, as well as experience in other areas and are fully supportive of
our efforts and plans. They are fully aligned with us on the long-term
vision for the company and are committed to support our efforts in discovery
and development. However, they are also aware of the fact that going
forward, once we start registration-directed Phase III clinical development
activities and commercialization of our lead asset, and in parallel advance
our early portfolio of clinical pipeline candidates, the investment levels
will be quite high. They are committed to supporting us but at the same time
recognize that additional investors and partners may help maximize the
opportunities. However, it has to be at the right time, at least from the
value creation perspective, we need to be at the right spot in development
of our products, at the right inflection point. We do not want to partner
too soon or too late, so we believe that sometime in the middle of next year
will be a good time for us to seriously consider and execute some of these
strategic options.

CEOCFO: When you are talking with members
of the investment community is there a general understanding of what you are
doing and how it might be different from others?

Dr. Gupta, PhD:I think the
investment community is very smart. They see a lot of things and they are
aware of what is happening in the world of immunology or oncology and what
kinds of drugs are being developed and what is hot. They clearly have their
finger on the pulse, so they do understand what we are doing as a company.
We have talked to a number of investors; there is a lot of interest,
clearly, from the investment community. We continue to receive very good and
positive feedback regarding our lead program ASN002, which we are developing
in atopic dermatitis and also plan to evaluate in multiple
immunologic/autoimmune indications. In addition, they appreciate that Asana
has a broad development pipeline, which gives us multiple shots on goal,
both in immunology and inflammation as well as in oncology.

CEOCFO: Why pay attention to Asana
BioSciences?

Dr. Gupta, PhD:Asana is a
unique company not only in how efficiently we are developing our drugs and
executing our programs, but also in the depth and breadth of our portfolio.
We are a highly efficient and experienced management team, which makes very
good, timely, data driven decisions. Our efficiency is probably one of the
best amongst our peers. We are developing a broad portfolio of assets in
areas of high unmet medical need. We are working on fast follower targets,
but at the same time, we are highly focused on differentiation from the
competition and developing best-in-class drugs. We continue to execute
multiple programs in parallel quite efficiently, and we have more INDs to be
filed in the next three to six months. Therefore, we believe Asana can be
viewed as an emerging pharmaceutical company, not as a single asset biotech.
Indeed, there are multiple programs in clinical development. Our portfolio,
efficient process of decision making, and execution of our programs is quite
unique and attractive from an industry perspective.

“Asana is a unique company not only in how efficiently we are developing our
drugs and executing our programs, but also in the depth and breadth of our
portfolio. We are a highly efficient and experienced management team, which
makes very good, timely, data driven decisions. Our efficiency is probably
one of the best amongst our peers. We are developing a broad portfolio of
assets in areas of high un-met medical need. We are working on fast follower
targets, but at the same time, we are highly focused on differentiation from
the competition and developing best-in-class drugs.”
- Dr. Sandeep Gupta